Manager Quality Assurance

CSL Limited; City of Melbourne; On-site; AUD 120,000 - 160,000; Full time

Job summary

CSL Behring in Melbourne, Australia, seeks a Lead QA to oversee Bulk Quality Operations, ensuring GMP compliance and alignment with regulatory expectations.

You will lead a quality team, drive investigations, CAPAs, deviation management and change controls, and partner with manufacturing, engineering and QA. This role also supports regulatory inspections, risk assessments and continuous improvement to safeguard product quality and patient safety.

Qualifications

• Bachelor's degree or higher in science, biotechnology, pharmaceutical science, engineering or related discipline.
• Minimum 5 years in pharmaceutical manufacturing, QA or regulated environment.
• Strong knowledge of GMP, quality systems, investigations, deviations, CAPAs and change control.
• Experience supporting audits and regulatory inspections.
• Excellent stakeholder management, problem-solving and communication skills.

Responsibilities

• Lead a quality team responsible for batch review, change control approvals and deviations.
• Provide leadership, mentoring and technical guidance across Bulk Quality team.
• Drive CI initiatives to enhance compliance, efficiency and operational excellence.
• Provide quality oversight for manufacturing and support activities ensuring GMP and regulatory compliance.
• Act as primary quality contact for operational escalations and quality-related decisions.
• Partner with Operational Services and cross-functional teams to close quality events and achieve site KPIs.
• Review and approve quality documentation, risk assessments, validation protocols, investigations, CAPAs and change controls.
• Lead and support deviation management including root cause investigations and corrective actions.
• Support regulatory inspections and audits, representing Quality Assurance as needed.

Skills

People leadership

GMP expertise

QA oversight

Regulatory inspections

Education

Bachelor's degree in science or related

Job description

As the Lead QA in our Bulk Quality Operations team, you will provide quality oversight across manufacturing and ensure compliance with GMP requirements, regulatory expectations, and internal quality standards. You will partner closely with manufacturing, operational services, engineering, and quality teams to support product quality, drive compliance, lead investigations and change controls, and foster a culture of continuous improvement.

Key responsibilities

• Lead a quality team that is responsible for batch review, change control approval and incident/deviations
• Provide leadership, mentoring, and technical guidance across the Bulk Quality team
• Drive continuous improvement initiatives to enhance compliance, efficiency, and operational excellence
• Provide quality oversight for manufacturing and support activities, ensuring compliance with GMP and regulatory requirements
• Act as the primary quality contact for operational escalations and quality-related decision making
• Partner with Operational Services and cross-functional teams to ensure timely closure of quality events and achievement of site KPIs
• Review and approve quality documentation, risk assessments, validation protocols, investigations, CAPAs, and change controls
• Lead and support deviation management activities, including root cause investigations and implementation of effective corrective and preventive actions
• Support regulatory inspections and audits, representing Quality Assurance where required

About you

• Demonstrated people leadership experience, with a strong ability to lead, coach, and mentor teams while remaining actively involved in day-to-day operational responsibilities
• A minimum of 5 years' experience in a pharmaceutical manufacturing, quality assurance, or regulated environment
• A bachelor's degree in science, Biotechnology, Pharmaceutical Science, Engineering, Biological Sciences, or a related discipline
• Strong knowledge of GMP, quality systems, investigations, deviations, CAPAs, and change control processes
• Experience supporting audits and regulatory inspections
• Demonstrated stakeholder management skills
• Excellent problem-solving, decision-making, and risk assessment capabilities
• Strong communication and collaboration skills, with the ability to influence across multiple functions

About us

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

This is an excited opportunity to play a key role in ensuring product quality and regulatory compliance while contributing to the manufacture of life‑saving therapies. You'll work with a highly collaborative team and have the opportunity to drive improvements that directly impact patients and business performance.